Physiological ResponsesNCT05516264
Behavioural and Physiological Responses to Dog Visits in Nursing Homes
A study of Physiological Responses and Behavior, run by University of Aarhus at 1 site in Denmark.
Trial summary
In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiological Responses, Behavior, Mood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age of 65 years or more
- Able to sit during visits (either in a chair or in a bed)
Who cannot join
- Known allergy to dogs
- Known fear of dogs
Trial locations and contacts
1 site in 1 country.
About this study
In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.
Read the detailed description
The residents will receive six 10-minute visits, three visits with a dog and three without a dog, with a week-long break in between the two visit types. The participants will be randomly assigned to receive either the three dog visits or the three visits without a dog first. The visits will be from the same person, and the dog visits will be accompanied with the same dog each time. During dog visits, the dog will be available for touch, and the resident will be encouraged to interact with the dog.
Before each visit the resident is fitted with the equipment for measuring continuously recorded physiological measures and then relaxes for 30 minutes. Immediately before and five and 30 minutes after each visit, the investigators obtain a saliva sample to detect cortisol levels.
The behaviour of the participants will be video recorded during the visits to quantify the frequency and duration of predefined behavioural elements, using ethological methodology. The investigators will quantify the participants' activity during the visits as well as the frequency and duration of tactile contact with the dog, and verbal communication with the dog and the visitor.
In addition, the visitor and the observer present during the visit will subjectively assess the resident's perception of the visit.
- Conditions
- Physiological Responses, Behavior, Mood
- Being tested
- Dog visits/control visits, Control visits/dog visits
- Keywords
- Human-animal contact, Non-invasive measure
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog visits/control visitsBehavioural
See arm description above
Control visits/dog visitsBehavioural
See arm description above
| Study group | Role | What they receive |
|---|---|---|
| Dog visits first | Other | Participants receive the three dogs visits first and then, after a break, receive the three control visits Receives: Behavioral: Dog visits/control visits |
| Control visits first | Other | Participants receive the three control visits first and then, after a break, receive the three dog visits Receives: Behavioral: Control visits/dog visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate
The test person wears a device placed on the upper arm
Measured: During visit no. 6, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: During visit no. 6, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 1, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 2, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 3, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 4, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 5, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
The test persons behaviour is observed
Measured: During visit no. 6, from 30 minutes before the visit to 30 minutes after
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 1, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 2, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 3, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 4, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 5, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 6, 2 minutes before visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 1, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 2, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 3, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 4, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 5, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 6, 5 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 1, 30 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 2, 30 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 3, 30 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 4, 30 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 5, 30 minutes after visit
Salivary cortisol
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Measured: Visit 6, 30 minutes after visit
Secondary outcomes (12)
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 1
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 2
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 3
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 4
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 5
The visitor's and observer's perception of how the visit was experienced by the test person.
Minimum value 0 (worst possible visit) to 100 (best possible visit)
Measured: 5 minutes after visit 6
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 1
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 2
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 3
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 4
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 5
Visual analoque scale of the testpersons' evaluation of the visit
Minimum value 0 (worst possible experience) to 100 (best possible experience)
Measured: 5 minutes after visit 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start5 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ResponsesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants from 2 nursing homes (25+25) are all receive three visit with a dog and three without a dog. It is randomised whter participents receive the dog visits first or last.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516264
- Sponsor's protocol ID
- ANIMAL CONTACT 4
- Status last verified
- Apr 2024
- First submitted
- 19 Aug 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Physiological Responses to Dog Visits in Nursing Homes
- ClinicalTrials.gov ID
- NCT05516264
- Acronym / sponsor ID
- ANIMAL CONTACT 4
- Conditions
- Physiological Responses, Behavior, Mood
- Keywords
- Human-animal contact, Non-invasive measure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.
Detailed description
The residents will receive six 10-minute visits, three visits with a dog and three without a dog, with a week-long break in between the two visit types. The participants will be randomly assigned to receive either the three dog visits or the three visits without a dog first. The visits will be from the same person, and the dog visits will be accompanied with the same dog each time. During dog visits, the dog will be available for touch, and the resident will be encouraged to interact with the dog.
Before each visit the resident is fitted with the equipment for measuring continuously recorded physiological measures and then relaxes for 30 minutes. Immediately before and five and 30 minutes after each visit, the investigators obtain a saliva sample to detect cortisol levels.
The behaviour of the participants will be video recorded during the visits to quantify the frequency and duration of predefined behavioural elements, using ethological methodology. The investigators will quantify the participants' activity during the visits as well as the frequency and duration of tactile contact with the dog, and verbal communication with the dog and the visitor.
In addition, the visitor and the observer present during the visit will subjectively assess the resident's perception of the visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants from 2 nursing homes (25+25) are all receive three visit with a dog and three without a dog. It is randomised whter participents receive the dog visits first or last.
| Arm | Type | Receives |
|---|---|---|
| Dog visits first | Other | Behavioral: Dog visits/control visitsParticipants receive the three dogs visits first and then, after a break, receive the three control visits |
| Control visits first | Other | Behavioral: Control visits/dog visitsParticipants receive the three control visits first and then, after a break, receive the three dog visits |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age of 65 years or more
- Able to sit during visits (either in a chair or in a bed)
Key exclusion criteria (2 listed)
- Known allergy to dogs
- Known fear of dogs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog visits/control visitsSee arm description above | Behavioural | Dog visits first |
| Control visits/dog visitsSee arm description above | Behavioural | Control visits first |
Primary outcome
Heart rate
Time frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate
Time frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate
Time frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate
Time frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate
Time frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate
Time frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
Heart rate variability
Time frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
Behaviour during visits
Time frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Behaviour during visits
Time frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Behaviour during visits
Time frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Behaviour during visits
Time frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Behaviour during visits
Time frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Behaviour during visits
Time frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
Salivary cortisol
Time frame: Visit 1, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 2, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 3, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 4, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 5, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 6, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 1, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 2, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 3, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 4, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 5, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 6, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 1, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 2, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 3, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 4, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 5, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Salivary cortisol
Time frame: Visit 6, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
12 secondary outcomes
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 1
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 2
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 3
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 4
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 5
The visitor's and observer's perception of how the visit was experienced by the test person.
Time frame: 5 minutes after visit 6
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 1
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 2
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 3
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 4
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 5
Visual analoque scale of the testpersons' evaluation of the visit
Time frame: 5 minutes after visit 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Physiological Responses and Behavior, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.